Home NDC 68788-8534 Mupirocin
Product NDC 68788-8534
11-digit product format 687888534
Labeler code 68788
Product ID 68788-8534_209dd715-07c5-49ac-8a5c-9eb0e1fd5b76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mupirocin
Dosage form OINTMENT
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA090480
Marketing category ANDA
Marketing start 2023-10-23
Substance MUPIROCIN
Active strength 20 mg/g
Pharmacologic classes RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 68788-8534 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-8534 68788-8534-2 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090480-001 MUPIROCIN MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090480-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090480-001 MUPIROCIN 2% OINTMENT / TOPICAL AB 2011-06-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mupirocin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MUPIROCIN 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D0GX863OA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106346 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8534-2 Mupirocin 22 g in 1 TUBE OINTMENT 22 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8534 MUPIROCIN OINTMENT [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 1 package rows 20250117_06a4ee22-d8f8-4a8a-8666-82b14f2d8476.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8534-2 68788853402 22 g in 1 TUBE (68788-8534-2) 22 g 2023-10-23 No No Current